Catheter-Associated Urinary Tract Infections (CAUTIs)(EARLY-KTx)NCT07681843
Early (Postoperative Day 3) Versus Standard (Postoperative Day 6) Urethral Catheter Removal After Living Donor Kidney Transplantation
A study testing Early urethral catheter removal and Standard urethral catheter removal in people with Catheter-Associated Urinary Tract Infections (CAUTIs) and Kidney Transplantation, run by Fahim Kanani at 1 site in Israel.
Trial summary
Urinary tract infection is one of the most common complications after kidney transplantation and is associated with increased morbidity, prolonged hospitalization, and impaired graft outcomes. The duration of urethral catheterization is a modifiable risk factor for catheter-associated urinary tract infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Associated Urinary Tract Infections (CAUTIs), Kidney Transplantation
- What is being tested?
- Early urethral catheter removal and Standard urethral catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Undergoing living donor kidney transplantation
- Pre-emptive kidney transplantation
- Preserved urine output
- Ability to provide written informed consent
Who cannot join
- Previous bladder or urethral surgery
- Complex urinary tract reconstruction
- Neurogenic bladder
- Active urinary tract infection at the time of transplantation
- Pregnancy
- Body mass index (BMI) <18 or >40 kg/m²
- Intraoperative blood loss >1000 mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Standard Urethral Catheter Removal After Kidney Transplantation
Urinary tract infection is one of the most common complications after kidney transplantation and is associated with increased morbidity, prolonged hospitalization, and impaired graft outcomes. The duration of urethral catheterization is a modifiable risk factor for catheter-associated urinary tract infection. This randomized controlled trial compares early catheter removal on postoperative day 3 with standard catheter removal on postoperative day 6 in living donor kidney transplant recipients. The primary objective is to determine whether early catheter removal reduces 30-day urinary tract infections without increasing urinary complications requiring intervention.
Read the detailed description
For ClinicalTrials.gov, the Detailed Description should be scientific and comprehensive, but not written like the introduction of a manuscript. It should explain the rationale, study design, intervention, and outcomes in language understandable to both clinicians and the public.
I would recommend the following:
# Detailed Description
Urinary tract infection (UTI) is among the most frequent complications following kidney transplantation and remains a major source of postoperative morbidity. Catheter-associated urinary tract infections (CAUTIs) account for a substantial proportion of these infections because urethral catheterization is routinely performed after transplantation to protect the ureterovesical anastomosis, ensure continuous bladder drainage, and facilitate monitoring of urine output during the early postoperative period. However, prolonged catheterization increases the risk of bacterial colonization and infection, which may result in symptomatic UTI, pyelonephritis, bacteremia, prolonged hospitalization, increased healthcare costs, and potentially adverse graft outcomes.
The optimal duration of urethral catheterization after kidney transplantation remains uncertain. Current practice varies considerably among transplant centers, with catheter removal occurring anywhere from postoperative day (POD) 1 to POD 7 or later. This variation reflects the lack of high-quality randomized evidence balancing the potential benefits of earlier catheter removal against concerns regarding urinary retention, urinary leak, ureteral complications, and the need for catheter reinsertion.
Several observational studies and small randomized trials have suggested that early catheter removal may substantially reduce the incidence of postoperative urinary tract infections without increasing clinically significant urological complications. Nevertheless, differences in patient populations, surgical techniques, catheter removal protocols, and outcome definitions have limited the generalizability of previous findings. Consequently, no international consensus exists regarding the optimal timing of catheter removal after kidney transplantation.
The EARLY-KTx trial is a prospective, single-center, randomized controlled trial designed to compare early urethral catheter removal with standard catheter removal following living donor kidney transplantation. Eligible participants will be randomly assigned in a 1:1 ratio to undergo catheter removal either on postoperative day 3 (experimental group) or postoperative day 6 (standard care group). The study uses an open-label design because catheter removal timing cannot be concealed from participants or treating clinicians; however, whenever feasible, outcome assessment and data analysis will be performed by investigators blinded to treatment allocation (Prospective Randomized Open-label Blinded Endpoint [PROBE] design).
All participants will undergo standardized kidney transplantation using the institutional surgical technique, including ureteroneocystostomy with routine double-J ureteral stent placement, standardized perioperative antimicrobial prophylaxis, and standardized postoperative care. Both study groups will receive identical perioperative management, differing only in the timing of urethral catheter removal.
The primary objective is to determine whether early catheter removal reduces the incidence of urinary tract infection within 30 days after transplantation without increasing clinically significant urinary complications. The primary efficacy outcome is the incidence of microbiologically confirmed urinary tract infection, including asymptomatic bacteriuria, symptomatic urinary tract infection, complicated urinary tract infection, or transplant pyelonephritis occurring within 30 days after transplantation. The primary safety outcome is the occurrence of urinary complications requiring intervention, including urinary leak, ureteral stenosis, or other complications requiring catheter reinsertion, ureteral stenting, nephrostomy, or surgical intervention.
Secondary outcomes include urinary retention requiring recatheterization, postoperative pain, voiding symptoms, patient satisfaction, length of hospital stay, graft function assessed by serum creatinine, postoperative complications, reoperation, healthcare utilization, and cost-effectiveness. Participants will be followed for 12 months after transplantation to evaluate both early postoperative outcomes and medium-term graft and urological outcomes.
The findings of this trial are expected to provide high-quality evidence regarding the optimal timing of urethral catheter removal after kidney transplantation. If early catheter removal is shown to reduce infectious complications without compromising patient safety, the results may contribute to standardization of postoperative management protocols and improve outcomes for kidney transplant recipients.
- Being tested
- Early urethral catheter removal, Standard urethral catheter removal
- Keywords
- Kidney transplantation, Foley catheter, Urinary tract infection, Catheter-associated urinary tract infection, Randomized trial, Living donor kidney transplantation
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early urethral catheter removalProcedure or surgery
Also called Early Foley catheter removal, Postoperative day 3 catheter removal, POD3 catheter removal
Participants randomized to the experimental arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 3 (72 ± 6 hours) following living donor kidney transplantation. All participants will receive standardized perioperative care, including routine double-J ureteral stent placement, standardized antibiotic prophylaxis, standardized drain management, and identical postoperative monitoring. After catheter removal, participants will be assessed for spontaneous voiding, urinary retention, post-void residual volume, urinary tract infection, and urinary complications according to the study protocol. If clinically indicated, temporary recatheterization will be performed using predefined protocol criteria.
Standard urethral catheter removalProcedure or surgery
Also called Standard Foley catheter removal, Postoperative day 6 catheter removal, POD6 catheter removal
Participants randomized to the control arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 6 (144 ± 12 hours) following living donor kidney transplantation. All other perioperative and postoperative management will be identical to the experimental arm, including standardized surgical technique, ureteral stent placement, antibiotic prophylaxis, drain management, postoperative monitoring, and follow-up. Outcomes will be assessed using the same predefined protocol and follow-up schedule.
| Study group | Role | What they receive |
|---|---|---|
| Early Catheter Removal | Experimental | Urethral catheter removal on postoperative day 3 (72 ± 6 hours). Receives: Procedure: Early urethral catheter removal |
| Standard Catheter Removal | Active comparator | Urethral catheter removal on postoperative day 6 (144 ± 12 hours). Receives: Procedure: Standard urethral catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirty-day urinary tract infection
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
Measured: 30 days after transplantation
Secondary outcomes (4)
Urinary leak requiring intervention
Incidence of clinically significant urinary leak occurring within 30 days after transplantation, confirmed by clinical findings and/or imaging, and requiring therapeutic intervention including prolonged catheterization, ureteral stenting, percutaneous nephrostomy, percutaneous drainage, or surgical repair.
Measured: 30 days
Ureteral stenosis requiring intervention
Incidence of ureteral stenosis diagnosed during the first 12 months after transplantation based on imaging and clinical assessment, requiring intervention such as ureteral stent placement, percutaneous nephrostomy, endourological treatment, or surgical reconstruction.
Measured: 12 months
Acute urinary retention requiring re-catheterization
Incidence of acute urinary retention following catheter removal requiring temporary urethral catheter reinsertion, defined according to the study protocol by inability to void within the predefined observation period, symptomatic urinary retention, or elevated post-void residual volume requiring intervention.
Measured: 5 days
Length of hospital stay
Total duration of postoperative hospitalization measured as the number of days from kidney transplantation to discharge from the index hospital admission.
Measured: From transplantation until hospital discharge (approximately 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 May 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated Urinary Tract Infections (CAUTIs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to undergo urethral catheter removal on postoperative day 3 or postoperative day 6 following living donor kidney transplantation. Both groups receive identical perioperative management except for catheter removal timing.
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fahim Kanani
- Sponsor type
- University, hospital or other
- Collaborators
- Rabin Medical Center
- Responsible party
- Sponsor-investigator, Fahim Kanani, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681843
- Sponsor's protocol ID
- RMC-0154-26
- Acronym
- (EARLY-KTx)
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the primary publication, including demographic characteristics, baseline clinical variables, intervention assignment, primary and secondary outcome measures, and the study data dictionary, will be made available to qualified researchers upon reasonable request. Data will be shared only after publication of the primary study results, following approval by the study investigators and Rabin Medical Center, execution of an appropriate data use agreement, and confirmation that the proposed use is scientifically and ethically appropriate. All shared data will be fully de-identified in accordance with applicable privacy regulations and institutional policies.
Publications
Zomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Castelo M, et al. Early urinary catheter removal after rectal surgery: systematic review and meta-analysis. BJS Open. 2020;4(4):545-553. European Renal Best Practice Guidelines. Nephrology Dialysis Transplantation. 2015;30(11):1790-1797. CDC Guidelines for Prevention of Catheter-Associated Urinary Tract Infections. 2019. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Zomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. European Renal Best Practice (ERBP) Guideline on Kidney Donor and Recipient Care. Nephrology Dialysis Transplantation. 2015.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Standard Urethral Catheter Removal After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07681843
- Acronym / sponsor ID
- (EARLY-KTx) / RMC-0154-26
- Keywords
- Kidney transplantation, Foley catheter, Urinary tract infection, Catheter-associated urinary tract infection, Randomized trial, Living donor kidney transplantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Fahim KananiUniversity, hospital or other
- Collaborators
- Rabin Medical Center
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary tract infection is one of the most common complications after kidney transplantation and is associated with increased morbidity, prolonged hospitalization, and impaired graft outcomes. The duration of urethral catheterization is a modifiable risk factor for catheter-associated urinary tract infection. This randomized controlled trial compares early catheter removal on postoperative day 3 with standard catheter removal on postoperative day 6 in living donor kidney transplant recipients. The primary objective is to determine whether early catheter removal reduces 30-day urinary tract infections without increasing urinary complications requiring intervention.
Detailed description
For ClinicalTrials.gov, the Detailed Description should be scientific and comprehensive, but not written like the introduction of a manuscript. It should explain the rationale, study design, intervention, and outcomes in language understandable to both clinicians and the public.
I would recommend the following:
# Detailed Description
Urinary tract infection (UTI) is among the most frequent complications following kidney transplantation and remains a major source of postoperative morbidity. Catheter-associated urinary tract infections (CAUTIs) account for a substantial proportion of these infections because urethral catheterization is routinely performed after transplantation to protect the ureterovesical anastomosis, ensure continuous bladder drainage, and facilitate monitoring of urine output during the early postoperative period. However, prolonged catheterization increases the risk of bacterial colonization and infection, which may result in symptomatic UTI, pyelonephritis, bacteremia, prolonged hospitalization, increased healthcare costs, and potentially adverse graft outcomes.
The optimal duration of urethral catheterization after kidney transplantation remains uncertain. Current practice varies considerably among transplant centers, with catheter removal occurring anywhere from postoperative day (POD) 1 to POD 7 or later. This variation reflects the lack of high-quality randomized evidence balancing the potential benefits of earlier catheter removal against concerns regarding urinary retention, urinary leak, ureteral complications, and the need for catheter reinsertion.
Several observational studies and small randomized trials have suggested that early catheter removal may substantially reduce the incidence of postoperative urinary tract infections without increasing clinically significant urological complications. Nevertheless, differences in patient populations, surgical techniques, catheter removal protocols, and outcome definitions have limited the generalizability of previous findings. Consequently, no international consensus exists regarding the optimal timing of catheter removal after kidney transplantation.
The EARLY-KTx trial is a prospective, single-center, randomized controlled trial designed to compare early urethral catheter removal with standard catheter removal following living donor kidney transplantation. Eligible participants will be randomly assigned in a 1:1 ratio to undergo catheter removal either on postoperative day 3 (experimental group) or postoperative day 6 (standard care group). The study uses an open-label design because catheter removal timing cannot be concealed from participants or treating clinicians; however, whenever feasible, outcome assessment and data analysis will be performed by investigators blinded to treatment allocation (Prospective Randomized Open-label Blinded Endpoint [PROBE] design).
All participants will undergo standardized kidney transplantation using the institutional surgical technique, including ureteroneocystostomy with routine double-J ureteral stent placement, standardized perioperative antimicrobial prophylaxis, and standardized postoperative care. Both study groups will receive identical perioperative management, differing only in the timing of urethral catheter removal.
The primary objective is to determine whether early catheter removal reduces the incidence of urinary tract infection within 30 days after transplantation without increasing clinically significant urinary complications. The primary efficacy outcome is the incidence of microbiologically confirmed urinary tract infection, including asymptomatic bacteriuria, symptomatic urinary tract infection, complicated urinary tract infection, or transplant pyelonephritis occurring within 30 days after transplantation. The primary safety outcome is the occurrence of urinary complications requiring intervention, including urinary leak, ureteral stenosis, or other complications requiring catheter reinsertion, ureteral stenting, nephrostomy, or surgical intervention.
Secondary outcomes include urinary retention requiring recatheterization, postoperative pain, voiding symptoms, patient satisfaction, length of hospital stay, graft function assessed by serum creatinine, postoperative complications, reoperation, healthcare utilization, and cost-effectiveness. Participants will be followed for 12 months after transplantation to evaluate both early postoperative outcomes and medium-term graft and urological outcomes.
The findings of this trial are expected to provide high-quality evidence regarding the optimal timing of urethral catheter removal after kidney transplantation. If early catheter removal is shown to reduce infectious complications without compromising patient safety, the results may contribute to standardization of postoperative management protocols and improve outcomes for kidney transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to undergo urethral catheter removal on postoperative day 3 or postoperative day 6 following living donor kidney transplantation. Both groups receive identical perioperative management except for catheter removal timing.
| Arm | Type | Receives |
|---|---|---|
| Early Catheter Removal | Experimental | Procedure: Early urethral catheter removalUrethral catheter removal on postoperative day 3 (72 ± 6 hours). |
| Standard Catheter Removal | Active comparator | Procedure: Standard urethral catheter removalUrethral catheter removal on postoperative day 6 (144 ± 12 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Undergoing living donor kidney transplantation
- Pre-emptive kidney transplantation
- Preserved urine output
- Ability to provide written informed consent
Key exclusion criteria (7 listed)
- Previous bladder or urethral surgery
- Complex urinary tract reconstruction
- Neurogenic bladder
- Active urinary tract infection at the time of transplantation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early urethral catheter removalAlso: Early Foley catheter removal, Postoperative day 3 catheter removal, POD3 catheter removalParticipants randomized to the experimental arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 3 (72 ± 6 hours) following living donor kidney transplantation. All participants will receive standardized perioperative care, including routine double-J ureteral stent placement, standardized antibiotic prophylaxis, standardized drain management, and identical postoperative monitoring. After catheter removal, participants will be assessed for spontaneous voiding, urinary retention, post-void residual volume, urinary tract infection, and urinary complications according to the study protocol. If clinically indicated, temporary recatheterization will be performed using predefined protocol criteria. | Procedure or surgery | Early Catheter Removal |
| Standard urethral catheter removalAlso: Standard Foley catheter removal, Postoperative day 6 catheter removal, POD6 catheter removalParticipants randomized to the control arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 6 (144 ± 12 hours) following living donor kidney transplantation. All other perioperative and postoperative management will be identical to the experimental arm, including standardized surgical technique, ureteral stent placement, antibiotic prophylaxis, drain management, postoperative monitoring, and follow-up. Outcomes will be assessed using the same predefined protocol and follow-up schedule. | Procedure or surgery | Standard Catheter Removal |
Primary outcome
Thirty-day urinary tract infection
Time frame: 30 days after transplantation
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
4 secondary outcomes
Urinary leak requiring intervention
Time frame: 30 days
Ureteral stenosis requiring intervention
Time frame: 12 months
Acute urinary retention requiring re-catheterization
Time frame: 5 days
Length of hospital stay
Time frame: From transplantation until hospital discharge (approximately 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publicationZomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Castelo M, et al. Early urinary catheter removal after rectal surgery: systematic review and meta-analysis. BJS Open. 2020;4(4):545-553. European Renal Best Practice Guidelines. Nephrology Dialysis Transplantation. 2015;30(11):1790-1797. CDC Guidelines for Prevention of Catheter-Associated Urinary Tract Infections. 2019. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Zomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. European Renal Best Practice (ERBP) Guideline on Kidney Donor and Recipient Care. Nephrology Dialysis Transplantation. 2015.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the primary publication, including demographic characteristics, baseline clinical variables, intervention assignment, primary and secondary outcome measures, and the study data dictionary, will be made available to qualified researchers upon reasonable request. Data will be shared only after publication of the primary study results, following approval by the study investigators and Rabin Medical Center, execution of an appropriate data use agreement, and confirmation that the proposed use is scientifically and ethically appropriate. All shared data will be fully de-identified in accordance with applicable privacy regulations and institutional policies.
Related trials for Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruitingObservational study
Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli
Urinary Tract Infections (UTIs), Catheter-Associated Urinary Tract Infections (CAUTIs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early urethral catheter removal and Standard urethral catheter removal in people with Catheter-Associated Urinary Tract Infections (CAUTIs) and Kidney Transplantation, run by Fahim Kanani at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirty-day urinary tract infection (time frame: 30 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.